MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Autoimmune Disorder (1732); Failure of Implant (1924); Pain (1994); Weight Changes (2607)

Event Date 08/28/2015

Event Type  Injury  

Event Description

(b)(4) one (1) coil is lost somewhere.No idea where it went.Pain, cramping, bloating, weight gain.Developed an auto immune disease.Related?.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 7283485
• MDR Text Key: 100490002
• Report Number: MW5075360
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MEDICATIONS HAVE CHANGED THROUGH THE YEARS.
• Patient Outcome(s): Other
• Patient Age: 42.000 YR